Now Reading: Regulator mandates full review of globally unapproved drugs
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Regulator mandates full review of globally unapproved drugs
India's drug regulator has clarified that new drugs not yet approved anywhere in the world must undergo the full domestic regulatory process, even if Indian patients participated in global clinical trials. The…
The Story in Brief
India's drug regulator has clarified that new drugs not yet approved anywhere in the world must undergo the full domestic regulatory process, even if Indian patients participated in global clinical trials. The Central Drugs Standard Control Organisation (CDSCO) issued a circular on August 10 after noticing a rise in applications to import and market such drugs, which were either under review abroad or had completed phase III global trials with Indian subjects.
The CDSCO's internal technical committee decided that these investigational new drug applications must go through the IND division under the New Drugs and Clinical Trials Rules, 2019. An official said companies cannot use Indian participation in global trials as a shortcut. The move ensures thorough safety and efficacy evaluation before any such drug reaches Indian shores.
The Indian Opinion
The CDSCO's circular is a sensible safeguard, but it exposes a lazy narrative among some pharma firms: that global trials with Indian participants are a backdoor to market approval. The circular rightly closes that loophole. Now watch for how long the full review actually takes. Speed matters when patients wait for new treatments. Will the regulator match its scrutiny with efficiency?
Source: economictimes.indiatimes.com
This story was synthesised by AI from the source linked above.
